BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 1150|
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THIRD READING
Bill No: SB 1150
Author: Negrete McLeod (D)
Amended: As introduced
Vote: 21
SENATE BUS., PROF. & ECON. DEV. COMMITTEE : 6-1, 4/5/10
AYES: Negrete McLeod, Calderon, Correa, Oropeza, Walters,
Yee
NOES: Aanestad
NO VOTE RECORDED: Wyland, Florez
SENATE APPROPRIATIONS COMMITTEE : 10-0, 5/27/10
AYES: Kehoe, Alquist, Corbett, Denham, Leno, Price,
Walters, Wolk, Wyland, Yee
NO VOTE RECORDED: Cox
SUBJECT : Healing arts
SOURCE : Author
DIGEST : This bill requires for purposes of advertising
that a health care practitioner, as specified, include
specific professional designation following the health care
practitioners name, requires the Medical Board of
California (MBC) to adopt regulations on or before January
1, 2012, on the appropriate level of physician availability
necessary within clinics using laser or intense pulse light
devices for elective cosmetic surgery, and requires the MBC
to post on its Internet Web site a fact sheet to educate
the public about cosmetic surgery and the risks involved
CONTINUED
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with such surgeries. In addition, this bill revises the
existing definition of "outpatient settings" to include
fertility clinics that offer in vitro fertilization, and
states that it is the intent of the Legislature that the
Department of Public Health, pursuant to existing
regulations, inspect the peer review process utilized by
acute care hospitals.
ANALYSIS :
Existing law, the Business and Professions Code
1. Provides that it is unlawful for health care licensees
to disseminate or cause to be disseminated any form of
public communication, as defined, containing false,
fraudulent, misleading, deceptive statement, or image,
as specified, to induce the provision of services or the
rendering of a product relating to a professional
practice or business for which he or she is licensed,
and provides that any person so licensed who violates
this provision is guilty of a misdemeanor and that such
violation shall constitute good cause for revocation or
suspension of his or her license or other disciplinary
action including an administrative fine not to exceed
$10,000.
2. Requires the MBC in conjunction with the Board of
Registered Nursing (BRN), and in consultation with the
Physician Assistant Committee (PAC) and professionals in
the field, to review issues and problems relating to the
use of laser or intense light pulse devices for elective
cosmetic procedures by physicians and surgeons, nurses,
and physician assistants.
3. Specifies that the review conducted by the MBC, the BRN
and the PAC shall include the appropriate level of
physician supervision needed, the appropriate level of
training to ensure competency, guidelines for
standardized procedures and protocols that address
patient selection, education, instruction and informed
consent, use of topical agents, and procedures to be
followed in the event of complications or side effects
from treatment and procedures for governing emergency
and urgent care situations.
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4. Requires the MBC and the BRN to promulgate regulations
to implement changes determined to be necessary with
regard to the use of laser or intense pulse light
devices for elective cosmetic procedures by physicians
and surgeons, nurses and physicians assistants.
5. Requires the MBC to post on its Internet Web site
specified information in its possession, custody or
control regarding physicians and surgeons.
Existing law, the Health and Safety Code, Section 1248 et
seq.
1. Defines "outpatient setting" as any facility, clinic,
unlicensed clinic, center, office, or other setting that
is not part of a general acute care facility where
anesthesia is used.
2. Defines "accrediting agency" as a public or private
organization that is approved to issue certificates of
accreditation to outpatient settings by the MBC pursuant
to specified requirements.
3. Requires the MBC to obtain and maintain a list of all
accredited, certified, and licensed outpatient settings,
and to notify the public, upon inquiry, whether a
setting is accredited, certified, or licensed, or
whether the setting's accreditation, certification, or
license has been revoked.
4. Authorizes the MBC or an accrediting agency to, upon
reasonable prior notice and presentation of proper
identification, enter and inspect any outpatient setting
that is accredited by an accreditation agency at any
reasonable time to ensure compliance with, or
investigate an alleged violation of any standard of
accrediting agency or any provision of the specified
law.
5. Provides that before suspending or revoking a
certificate of accreditation, the accrediting agency
shall provide the outpatient setting with notice of
deficiencies and reasonable time to supply information
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demonstrating compliance with the standards of the
accrediting agency as well as the opportunity for a
hearing on the matter upon request of the outpatient
setting.
6. Defines treatment for infertility as procedures
consistent with established medical practices in the
treatment of infertility by licensed physicians and
surgeons including, but not limited to, diagnosis,
diagnostic tests, medication, surgery, and gamete
intrafallopian transfer. Defines in vitro fertilization
as the laboratory medical procedures involving the
actual in vitro fertilization process.
7. Defines acute care hospital as a health facility having
a duly constituted governing body with overall
administrative and professional responsibility and an
organized medical staff that provides 24-hour inpatient
care, including the following basic services: medical,
nursing, surgical, anesthesia, laboratory, radiology,
pharmacy, and dietary services.
8. Requires DPH to license and inspect health facilities,
including acute care hospitals. Requires DPH to conduct
periodic inspections of acute care hospitals no less
than once every three years.
This bill, within the Business and Professions Code:
1. Requires that any advertising by a chiropractor,
dentist, physician and surgeon, osteopathic physician
and surgeon, podiatrist, registered nurse, licensed
vocational nurse, psychologist, optometrist, physician
assistant and naturopathic doctor include specific
professional designation following the health care
practitioner's name.
2. Defines advertisement for purposes of #1) above to
include communication by means of mail, television,
radio, motion picture, newspaper, book, directory,
Internet or other electronic communication. Excludes
from the definition of advertisement the following:
medical directory released by a health care service plan
or a health insurer, a billing statement from a health
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care practitioner to a patient, or appointment reminder
from a health care practitioner to a patient. Also
excludes from the requirement in #1) above any
advertisement or business card disseminated by a health
care service plan relating to contracted providers, as
specified.
3. Specifies that the requirement in #1) does not apply
until January 1, 2012 to any advertisement that is
published annually and prior to July 1, 2011.
4. Requires the MBC to adopt regulations on or before
January 1, 2012 regarding the appropriate level of
physician availability needed within clinics or other
settings using laser or intense pulse light devices for
elective cosmetic procedures. Specifies that the
regulations to be adopted will not apply to laser or
intense pulse light devices approved by the federal Food
and Drug Administration for over-the-counter use by a
health care practitioner or by an unlicensed person on
himself/herself.
5. Requires the MBC to post on its Internet Web site an
easy to understand fact sheet to educate the public
about cosmetic surgery and procedures, including their
risks. Requires the fact sheet to include a
comprehensive list of questions for patients to ask
their physician and surgeon regarding cosmetic surgery.
This bill, within the Health and Safety Code, Section 1248
et seq.:
1. Includes in the existing definition of "outpatient
setting" facilities those that offer in vitro
fertilization, as specified.
2. Requires the MBC to adopt standards that it deems
necessary for outpatient settings that offer in vitro
fertilization.
3. Requires as part of the standards for operation and
approval of an outpatient setting that the outpatient
setting submit for approval by an accrediting agency at
the time of accreditation, a detailed plan, standardized
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procedures, and protocols to be followed in the event of
serious complications or side effects from surgery, as
specified.
4. Requires the MBC to notify the public whether a setting
is accredited, certified, or licensed, or the setting's
accreditation, certification, or license has been
revoked, suspended or placed on probation, or the
setting has received a reprimand by the accreditation
agency.
5. Requires an accrediting agency to immediately report to
the MBC if an outpatient setting's certificate for
accreditation has been denied.
6. Requires that every outpatient setting which is
accredited to be inspected by an accreditation agency
and may also be inspected by the MBC. Requires the MBC
to ensure that accreditation agencies inspect outpatient
settings.
7. Requires that the frequency of inspections depends upon
the type and complexity of the outpatient setting to be
inspected, and that inspections be conducted no less
than once every three years and as often as necessary by
the MBC to ensure the quality of care provided.
8. Requires reports on the results of each inspection to be
kept on file with the MBC or the accrediting agency
along with the plan of correction and the outpatient
setting comments and that the inspection report may
include a recommendation for re-inspection, and that all
inspection reports, lists of deficiencies, and plans of
correction be public records open to public inspection.
9. Deletes the requirement that the MBC or the accrediting
agency give reasonable prior notice and present proper
identification prior to an inspection.
10.Requires rather than just authorizes the MBC to evaluate
the performance of an approved accreditation agency no
less than every three years.
11.Provides that the outpatient setting shall agree with
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the accrediting agency upon a plan of correction when
they receive a notice of any deficiencies from the
accreditation agency and that during the time of
correction, the list of deficiencies and the plan of
correction shall be conspicuously posted in a clinic
location accessible to public view.
12.Requires an accreditation agency to immediately report
to the MBC if an outpatient setting has been issued a
reprimand or if the outpatient setting's certification
of accreditation has been suspended or revoked or if the
outpatient setting has been placed on probation.
13.Allows the MBC to issue a citation to the accrediting
agency if an accreditation agency is not meeting the
criteria set by the board. Specifies a system for the
issuance of a citation to an accreditation agency.
14.States the intent of the Legislature that the DPH,
pursuant to its existing regulation, inspect the peer
review process utilized by acute care hospitals as part
of its periodic inspections of those hospitals.
Background
Popularity of Plastic Surgery . American Society of Plastic
Surgery (ASPS) Web site states that the about 12.1 million
cosmetic procedures were performed in 2008, representing a
$10.3 billion industry. ASPS indicates that the top five
surgical procedures were breast augmentation, liposuction,
nose reshaping, eyelid surgery, and tummy tuck. Moreover,
ASPS points out that there were 10.7 million
minimally-invasive cosmetic procedures 2008. The top five
minimally-invasive procedures were Botox, hyaluronic acid
fillers, chemical peel, laser hair removal, and
microdermabrasion.
Accredited Outpatient Settings vs. Licensed Surgical
Clinics . The Health and Safety Code makes a distinction
between clinics licensed by the Department of Public Health
(DPH) and outpatient settings that are accredited by an
outside accrediting agency under the oversight of the MBC.
Clinics licensed by the DPH are non-physician owned, while
clinics accredited by an accreditation agency approved by
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the MBC are physician owned and operated. DPH-licensed
clinics include a clinic that is not part of a hospital and
provides ambulatory surgical care for patients who remain
less than 24-hours. As part of their licensure, clinics
under DPH's jurisdiction undergo inspection and must have
in place minimum standards of safety and staffing. On the
other hand, clinics that are physician-owned and are
accredited by an accreditation agency approved by the MBC
are commonly referred to as outpatient settings.
Outpatient setting is defined as a facility where
anesthesia is used in doses that when administered does not
have the probability of placing the patient at risk for
loss of the patient's life. These clinics are accredited
by one of four accreditation bodies that are approved by
the MBC. These accrediting agencies must ensure that
certification programs include standards for the operation
of outpatient settings such as safety and emergency
training requirements, licensure or certification of allied
health staff, provision of onsite equipment, medication and
trained personnel in a medical emergency, permit surgery
only by a licensee who has admitting privileges at a local
accredited or licensed acute care hospital, as defined, and
a system for patient care and monitoring procedures. The
four accrediting agencies approved by the MBC are the
American Association for Accreditation of Ambulatory
Surgery Facilities Inc., Accreditation Association for
Ambulatory Health Care, the Institute for Medical Quality
and the Joint Commission.
Assisted Reproductive Technology (ART) . According to the
Centers for Disease Control (CDC), ART includes all
fertility treatments in which both eggs and sperm are
handled. In general, ART procedures involve surgically
removing eggs from a woman's ovaries, combining them with
sperm in the laboratory, and returning them to the woman's
body or donating them to another woman. CDC points out
that of the approximately 62 million women of reproductive
age in 2002, about 1.2 million, or two percent, had an
infertility-related medical appointment within the previous
year, and eight percent had an infertility-related medical
visit at some point in the past. Infertility services
include medical tests to diagnose infertility, medical
advice and treatments to help a woman become pregnant, and
services other than routine prenatal care to prevent
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miscarriage. CDC also states that the number of infants
born after ART doubled in the United States from 1996-2004,
and in 2005, more than 134,000 ART procedures were
performed and approximately 52,000 infants were born as a
result of these procedures. According to a CDC 2008
report, infants conceived with ART are two to four times
more likely to have certain types of birth defects than
children conceived naturally.
The Fertility Clinic Success Rate and Certification Act of
1992, or Wyden Act, is federal legislation that was
implemented to ensure the quality of ART services and to
furnish consumers with reliable information on pregnancy
success rates of individual ART clinics. The Wyden Act
requires each ART program to report annually to the
Secretary of the Health and Human Services Agency through
the CDC, regarding pregnancy success rates and each embryo
laboratory used by the program and whether certified under
the Wyden Act. According to the 2006 ART report, there are
over 60 fertility clinics that reports success rates to the
CDC.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee analysis:
Fiscal Impact (in thousands)
Major Provisions 2010-11 2011-12
2012-13 Fund
Outpatient facility $289 $213$213Special*
Inspections (MBC)
* Medical Board of California Contingent Fund
SUPPORT : (Verified 5/27/10)
Medical Board of California
Procter and Gamble Company
OPPOSITION : (Verified 5/27/10)
California Hospital Association
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ARGUMENTS IN SUPPORT : The author's office states that
this bill attempts to guarantee the public's safety by
strengthening the regulation and oversight of fertility
clinics and surgical centers performing cosmetic
procedures, and ensures that quality of care standards are
in place at these clinics and checked by the appropriate
credentialing agency. The author's office points out that
recent event involving a woman who gave birth to octuplets
revealed that fertility clinics operate with little or no
state oversight. A clinic that assists women in any
reproductive technology should operate under specified
standards, guidelines and procedures and since most of
these clinics are physician-owned, this bill would require
these clinics to be accredited by an accrediting agency
approved by the MBC.
In addition, the author's office indicates that the number
of cosmetic procedures performed in the United States is
increasing at an alarming rate. According to the ASPS,
over 12 million cosmetic procedures were performed in 2008,
and $10.3 billion were spent on cosmetic procedures in the
United States. Consumers are also inundated everyday with
advertisements on how to look and feel better fast.
Medical spas, or facilities offering botox injections,
laser hair removal, and microdermabrasion are increasing in
popularity and are emerging in malls, city office buildings
and store fronts across the country. Although the Federal
Food and Drug Administration oversees the safety of
machines and skin-care products used, there is little
regulation of these medical spas to guarantee that
practitioners in these facilities are administering
treatments safely and patients are aware of the potential
risks associated with any treatments.
ARGUMENTS IN OPPOSITION : The California Hospital
Association (CHA) has taken an "oppose unless amended"
position on the provisions of this bill stating the intent
of the Legislature that the DPH, pursuant to its existing
regulations, inspect the peer review process utilized by
acute care hospitals as part of its periodic inspection of
these hospitals. CHA believes that such provisions are
unnecessary because the DPH already has authority to
inspect hospitals for compliance with California hospital
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licensing requirements, including requirements related to
hospital medical staffs
JJA:do 5/28/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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